Functional Assessment Of Cancer Therapy-Colorectal Research Articles

Patient-Reported Outcomes in Chinese Patients with Locally Advanced or Recurrent Colorectal Cancer After Pelvic Exenteration.

Pelvic exenteration (PE) is often the only curative treatment option for selected locally advanced and locally recurrent colorectal cancer associated with significant morbidity. Open and laparoscopic approaches were accepted for this procedure. This study aimed to examine the Chinese patient-reported outcomes (PROs) and health-related quality of life (HRQoL) after PE. A total of 122 enrolled participants were asked to complete PROs at baseline and 1, 3, 6, 9 and 12 months after PE. PROs included seven symptoms from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The HRQoL was assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C). The overall postoperative complication rate was 41.0%. Patients experienced lower physical and functional well-being and FACT-C 1month after surgery, then gradually recovered. The FACT-C score returned to baseline 9 months after surgery. Social and emotional well-being did not show signs of recovery until 6 months after the surgical procedure, and did not fully return to baseline until 12 months post-surgery. Symptom rates of insomnia, anxiety, discouragement, and sadness (composite score >0) did not improve significantly from baseline until 12 months after surgery. PE is a feasible treatment choice for locally advanced primary and recurrent colorectal cancer. Social, psychological, and emotional recovery in the Chinese population after PE tends to be slower compared with the physical condition.

Symptom Experience and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy – A Secondary Publication

Objective: To evaluate symptom experience and quality of life (QoL) and to identify the predictors of QoL among colorectal cancer patients undergoing chemotherapy. Methods: A cross-sectional study was conducted on 107 colorectal cancer patients at a university-affiliated hospital between June 1 and July 30, 2021. Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and Memorial Symptom Assessment Scale-Short Form (MSAS-SF) were used to assess symptom experience and QoL of these patients. Data were analyzed using Pearson’s correlation, t-test, ANOVA, and hierarchical multiple regression. Results: The mean QoL score for colorectal cancer patients was 88.78 ± 20.08. The most frequently experienced physical and psychological symptoms were numbness/tingling and worrying. Physical and psychological symptoms have a significant negative association with QoL. Perceived economic status was significantly associated with QoL in patients’ general characteristics. The regression analyses showed that high psychological symptoms (β = -0.63, P < 0.001), middle perceived economic status (β = -0.22, P = 0.009), and low perceived economic status (β = -0.36, P < 0.001) were statistically significant in predicting patients’ low QoL. Conclusion: Symptom experience and QoL are essential variables that should be acknowledged when delivering health care to colorectal cancer patients. More attention to the reduction and comprehensive symptom management of psychological distress could improve QoL among colorectal cancer patients.

Translation and Validation of a Vietnamese Version of the Colorectal Cancer Subscale for the Functional Assessment of Cancer Therapy - Colorectal Questionnaire.

There is a need for a validated Vietnamese translation of the colorectal cancer subscale (CCS) of the functional assessment of cancer therapy-colorectal (FACT-C) questionnaire to assess colorectal cancer-specific concerns of Vietnamese persons with colorectal cancer post-surgery. This study aims to translate and validate the CCS of FACT-C questionnaire in Vietnamese persons with colorectal cancer post-surgery. The nine-item CCS was translated following the functional assessment of chronic illness therapy (FACIT) translation methodology guidelines. Psychometric properties of a Vietnamese version of the CCS were evaluated with a sample of 135 participants who were randomly selected from three hospitals in Vietnam, utilizing a multistage sampling method. Construct validity was examined through confirmatory factor analysis (CFA), and reliability was assessed using Cronbach's α coefficients. These measures aimed to validate the psychometric properties of the Vietnamese nine-item CCS version. Descriptive statistics were used to analyze participant demographics with SPSS. The translated version demonstrated equivalence to the original English version. CFA results for the CCS Vietnamese version indicated that all 9 items were consistent with a unidimensional questionnaire (χ2 = 69.669, p > .05, df = 27, χ2/df = 2.58, RMSEA = .074, CFI = .917, TLI = .901, SRMR = .057). The Cronbach's α coefficient was .86, indicating high reliability. The Correlated Item-Total Correlation for the 9 items ranged from .39 to .76. The nine-item CCS Vietnamese version demonstrated appropriate translation, establishing its validity and reliability in measuring colorectal cancer-related concerns within the health-related quality of life among Vietnamese persons post-surgery.

Quality of life and symptom burden after rectal cancer surgery: a randomised controlled trial comparing patient-led versus standard follow-up

PurposeAfter curatively intended rectal cancer (RC) surgery, new follow-up strategies are warranted, seeking more individualised care and targeting health-related quality of life (HRQoL) and functional outcomes. The FURCA trial aimed to investigate the effect of patient-led follow-up on HRQoL and symptom burden 3 years after surgery.MethodsRC patients from four Danish centres were randomised 1:1 to intervention (patient-led follow-up with patient education and self-referral to a specialist nurse) or control (standard follow-up with five routine doctor visits). Patients in both groups had a computed tomography (CT) at 1 and 3 years. The primary outcome (HRQoL) was assessed by the Functional Assessment of Cancer Therapy – colorectal (FACT-C) score (Ward et al. in Qual Life Res. 8(3):181-95, 18). Secondary outcomes were functional measures, patient involvement and satisfaction and cancer recurrence at 3 years.ResultsFrom Feb 2016 to Aug 2018, 336 patients were included of whom 248 completed 3 years of follow-up. Between-group differences were found neither for the primary endpoint, nor for functional outcomes. The recurrence rate did not differ between the groups. Patient involvement and satisfaction were higher in the intervention group with statistical significance in almost half of the items.ConclusionsWe found no effect on HRQoL and symptom burden from patient-led follow-up, although it may improve patient-perceived involvement and satisfaction.Implications for Cancer SurvivorsThe findings in this study suggest that patient-led follow-up is a more tailored approach to meet cancer survivors’ needs and might improve their ability to cope with survivorship.ClinicalTrials.gov identifierR97-A6511-14-S23.

Association of treatment regimens with quality of life and overall survival in patients with metastatic colorectal cancer in Peru.

e15617 Background: Colorectal cancer is a significant public health concern in Peru. Metastatic colorectal cancer patients have limited treatment options, and the prognosis is generally poor. In recent years, treatment regimens for metastatic colorectal cancer have evolved significantly, with the emergence of targeted therapies and immunotherapy. However, little is known about the impact of these treatment regimens on quality of life and overall survival in the Peruvian population. The objective of this study is to investigate the association between treatment regimens and quality of life and overall survival (OS) in Peruvian metastatic colorectal cancer patients. Methods: This retrospective study included patients diagnosed with metastatic colorectal cancer between 2010 and 2020 at the AUNA clinic. Patients were included if they received chemotherapy as first-line treatment and were followed up for at least 6 months. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, which includes subscales for physical, social/family, emotional, and functional well-being, as well as colorectal cancer-specific concerns. Treatment regimens considered were: FOLFOX, FOLFIRI and others. Univariate and multivariate analyses were performed to identify factors associated with quality of life and overall survival. Results: A total of 193 patients were included in the study, and the median follow-up time was 14 months. The majority of patients were male (60.6%) and the median age was 57 years. The most common first-line chemotherapy regimens were FOLFOX (52.7%), FOLFIRI (23.5%), and capecitabine plus oxaliplatin (16.4%). The median overall survival was 14 months, and the 1-year overall survival rate was 52.8%. Patients treated with FOLFOX had significantly better quality of life scores than those treated with FOLFIRI or capecitabine plus oxaliplatin (p = 0.012). The difference in quality of life scores was most pronounced in the emotional and social/family well-being subscales. However, there was no significant difference in overall survival among the different treatment regimens (p = 0.344). Multivariate analysis showed that the presence of liver metastases and higher FACT-C scores were independent predictors of OS. Conclusions: Our study has shown that the choice of treatment regimen in Peruvian metastatic colorectal cancer patients can have a significant impact on their quality of life. Patients treated with FOLFOX as first line had better quality of life scores than those treated with FOLFIRI or capecitabine plus oxaliplatin, particularly in emotional and social/family well-being subscales. However, there was no significant difference in OS among the different treatment regimens. The presence of liver metastases and higher quality of life scores were found to be independent predictors of overall survival.

Short-term outcomes of health-related quality of life in patients with locally recurrent rectal cancer: multicentre, international, cross-sectional cohort study.

Overall survival rates for locally recurrent rectal cancer (LRRC) continue to improve but the evidence concerning health-related quality of life (HrQoL) remains limited. The aim of this study was to describe the short-term HrQoL differences between patients undergoing surgical and palliative treatments for LRRC. An international, cross-sectional, observational study was undertaken at five centres across the UK and Australia. HrQoL in LRRC patients was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 and functional assessment of cancer therapy - colorectal (FACT-C) questionnaires and subgroups (curative versus palliative) were compared. Secondary analyses included the comparison of HrQoL according to the margin status, location of disease and type of treatment. Scores were interpreted using minimal clinically important differences (MCID) and Cohen effect size (ES). Out of 350 eligible patients, a total of 95 patients participated, 74.0 (78.0 per cent) treated with curative intent and 21.0 (22.0 per cent) with palliative intent. Median time between LRRC diagnosis and HrQoL assessments was 4 months. Higher overall FACT-C scores denoting better HrQoL were observed in patients undergoing curative treatment, demonstrating a MCID with a mean difference of 18.5 (P < 0.001) and an ES of 0.6. Patients undergoing surgery had higher scores denoting a higher burden of symptoms for the EORTC CR29 domains of urinary frequency (P < 0.001, ES 0.3) and frequency of defaecation (P < 0.001, ES 0.4). Higher overall FACT-C scores were observed in patients who underwent an R0 resection versus an R1 resection (P = 0.051, ES 0.6). EORTC CR29 scores identified worse body image in patients with posterior/central disease (P = 0.021). Patients undergoing palliative chemoradiation reported worse HrQoL scores with a higher symptom burden on the frequency of defaecation scale compared with palliative chemotherapy (P = 0.041). Several differences in short-term HrQoL outcomes between patients undergoing curative and palliative treatment for LRRC were documented. Patients undergoing curative surgery reported better overall HrQoL and a higher burden of pelvic symptoms.

The long haul: Lived experiences of survivors following different treatments for advanced colorectal cancer: A qualitative study

Modern treatments, including surgery and palliative chemotherapy without surgery, enable longer survival for people with advanced/recurrent colorectal cancer (CRC). Qualitative research comparing the physical and psychosocial outcomes of these different treatments is lacking. This study therefore aimed to explore and compare the physical and psychosocial challenges and survivorship experiences of people who receive different treatments for advanced CRC, through a qualitative study. Adults with CRC who have undergone treatment for advanced/recurrent CRC were recruited 0.5-2 years post-surgery or, for palliative chemotherapy participants, 0.5-2 years post-diagnosis of advanced CRC. Qualitative semi-structured telephone interviews, analysed via framework analysis, explored quality of life (QoL) experiences. Demographic, clinical, and QoL data (Functional Assessment of Cancer Therapy - Colorectal (FACT-C), Distress Thermometer) were collected to characterise the sample and inform the framework analysis. A diverse sample of 38 participants (22 female) participated, with ages ranging 27-84 (Median=59), FACT-C 56-132 (Median=102), and distress 0-10 (median=3). Analysis of interviews revealed three overarching themes: 1) the overwhelming impact of protracted, complex illness; 2) compounding and interacting effects of multiple treatments, impacts, and multimorbidity; and 3) the long haul is unpredictable, bumpy, and wearing. These themes reveal that people with advanced CRC experience many challenges due to the complex nature of the illness, its treatment, and side effects. Survivors require continued multi-disciplinary supportive care throughout follow-up to manage survivorship challenges. Guideline-led survivorship care and routine monitoring of physical and psychosocial wellbeing throughout follow up is imperative to manage patient expectations and support advanced CRC survivors.

Impact of defecation dysfunction on quality of life in mid-low rectal cancer patients following sphincter-sparing surgery

ObjectiveA large proportion of mid-low rectal cancer patients develop low anterior resection syndrome (LARS) after Sphincter-sparing surgery. This study aimed to investigate the effect of LARS on quality of life (QoL) in Chinese rectal cancer patients following sphincter-sparing surgery. MethodsThis was a comparative cross-sectional study. Between Jan 2019 to Jun 2020, 146 mid-low rectal cancer patients following sphincter-sparing surgery were enrolled. The LARS score was used to assess bowel dysfunction. According to the LARS score, patients were divided into three levels, no LARS (n ​= ​34), minor LARS (n ​= ​60), and major LARS (n ​= ​52). The Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used to assess the QoL of the patients. ResultsThe major LARS group had a significantly shorter level of tumor from the dentate line than the no LARS group. The total FACT-C score of 146 patients was 98.45 ​± ​17.83. The total FACT-C score and the score of each dimension (physical, emotional, functional dimensions, and colorectal cancer subscale) were significantly different between the minor LARS and major LARS groups, as well as between the no LARS and major LARS groups. Subgroups analyses of the FACT-C score stratified by each item in the LARS scales showed that except for flatus incontinence, patients with different frequencies of other symptoms (bowel frequency, liquid stool incontinence, liquid stool incontinence, stool clustering, urgent bowel movement) had a significantly different total score of FACT (all P ​< ​0.01). ConclusionsThe LARS had a significant impact on the QoL in Chinese mid-low rectal cancer patients following sphincter-sparing surgery, especially in patients with major LARS.

Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC

BackgroundIn the BEACON CRC study (NCT02928224), encorafenib plus cetuximab with binimetinib {9.3 versus 5.9 months; hazard ratio (HR) [95% confidence interval (CI)]: 0.60 [0.47-0.75]} or without binimetinib [9.3 versus 5.9 months; HR (95% CI): 0.61 (0.48-0.77)] significantly improved overall survival (OS) compared with the previous standard of care (control) in patients with BRAF V600E metastatic colorectal cancer (mCRC). Quality of life (QoL) was a secondary endpoint, assessed using validated instruments.Patients and methodsBEACON CRC was a randomized, open-label, phase III study comparing encorafenib plus cetuximab with or without binimetinib and the investigator’s choice of irinotecan plus cetuximab or FOLFIRI plus cetuximab (chemotherapy control) in patients with previously treated BRAF V600E mCRC. Patient-reported QoL assessments included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC) and Functional Assessment of Cancer Therapy—Colorectal (FACT-C). The primary outcome for these tools was time to definitive 10% deterioration.ResultsEncorafenib plus cetuximab, both with and without binimetinib, was associated with longer median times to definitive 10% deterioration versus the control group in the EORTC Global Health Status scale [HR (95% CI): 0.65 (0.52-0.80) versus 0.61 (0.49-0.75), respectively] and the FACT-C functional well-being subscale [HR (95% CI): 0.62 (0.50-0.76) versus 0.58 (0.47-0.72), respectively]. Consistent results were observed across all subscales of the EORTC and FACT-C instruments. QoL was generally maintained during treatment for the global EORTC and FACT-C scales.ConclusionsIn addition to improving OS, encorafenib plus cetuximab with or without binimetinib delays QoL decline in previously treated patients with BRAF V600E-mutant mCRC.

The health-related quality of life changes following surgery in patients with colorectal cancer: a longitudinal study.

Colorectal cancer (CRC) is commonly treated with surgery and its success is frequently defined by cure rates. Impact on other aspects of health and wellbeing are less frequently considered in clinical practice. Patient-reported outcome measures (PROMs) provide a useful means of assessing such impacts. This study examines changes in health-related quality of life (HRQoL) after surgical resection using PROMs. A prospective, longitudinal study was undertaken in 49 adults receiving curative surgery for CRC. Participants completed the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) before surgery, and at 2 to 4 weeks, 3 and 6months post-surgery. Linear mixed models were used to analyse FACT-C wellbeing and subscale scores. Patients reported a clinically important deterioration in functional and physical wellbeing 2 to 4 weeks post-surgery (both P < 0.05); differences at 6months after surgery were trivial. Conversely, patients reported clinically important improvement in emotional wellbeing at 2 to 4 weeks post-surgery; this improvement was sustained at 3 and 6months post-surgery (all P < 0.05). For social wellbeing and colorectal cancer-specific concerns, changes from before surgery at follow-up assessments were not statistically significant (all P > 0.05). While physical aspects of HRQoL are affected in the short term by CRC surgery, clinically significant improvement in emotional wellbeing are reported early (2 to 4 weeks post-surgery). Future research may help identify patients who are at greater risk of surgical impacts on health and wellbeing.

Health-related quality of life in advanced colorectal cancer patients in China: a nationwide hospital-based survey.

BackgroundColorectal cancer (CRC) is one of the most common cancers in China, and most CRC patients have already reached an advanced stage by the time of initial diagnosis. Due to the loss of health as a result of cancer, it has consequence on the treatment which may affect the psychophysical and social impairment of CRC patients. These indicators (psychophysical, function and social impairment) affect the health-related quality of life (HRQOL). There are limited studies that focus on advanced CRC patients in China. This study aimed to assess the HRQOL and its associated factors of advanced CRC patients in China.MethodsThis was a cross-sectional, nationwide, hospital-based, and multi-center survey. According to the traditional administrative district definition, we selected 19 hospitals in 7 regions by multi-stage stratified sampling in China. For each eligible CRC patient with stage III or IV in the selected hospitals, socio-demographics, clinical information, and HRQOL were collected based on patients’ self-reporting and/or medical records between March 2020 and March 2021. Patients completed the Functional Assessment of Cancer Therapy Colorectal (FACT-C) plus-traditional Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-9.ResultsA total of 4,589 CRC patients (mean age 60.1 years, including 2,730 males and 1,859 females) were included. The total score of HRQOL in population was 128.2±24.70. There were significant differences in the overall score of HRQOL in gender, education level, occupation, region, disease type, and disease stage (P<0.05). The score of HRQOL was better in males, undergraduates and above, unemployed/laid-off, and southwestern and central China. Multivariate analysis showed that education level, occupation, location, number of hospitals visited and treatment methods, and gender were associated with utilities of CRC patients.ConclusionsThe HRQOL is an important outcome measure for CRC patients. The HRQOL scores differed according to socio-demographic and clinical characteristics, and findings of these factors were associated with education level, occupation, region, number of visited and treatment methods, and gender.

Radioembolization with chemotherapy for liver-dominant colorectal cancer: Time to subsequent treatment and quality of life in the EPOCH trial.

114 Background: The primary objective of the EPOCH trial evaluated potential benefit of adding second-line transarterial radioembolization (TARE) with yttrium-90 glass microspheres to chemotherapy compared to chemotherapy alone in patients with liver-dominant metastatic colorectal disease (mCRC). Secondary endpoints included time to deterioration of quality of life (TTDQoL). Methods: EPOCH was a 1:1 randomized, open-label, global, multicenter phase 3 trial. TTDQoL was assessed using the Functional Assessment of Cancer Therapy-colorectal (FACT-c) questionnaire and defined as the time from randomization to the change from baseline in FACT-c total score ≤ -7 points or date of death and was estimated using Kaplan-Meier analysis. Time to subsequent therapy was defined as the time from randomization to the start of subsequent therapy and was estimated using Kaplan-Meier analysis. Restricted mean survival time (RMST) analysis was used to estimate the area under Kaplan-Meier curves (AUC) for progression-free survival (PFS), hepatic PFS (hPFS), and TTDQoL, and the difference in AUC estimates between the two arms were assessed. The use of TheraSphere in the USA in the trial was under Investigational Device Exemption from FDA. Results: The EPOCH trial included 428 patients. Both primary endpoints of PFS (HR = 0.69, 95% CI: 0.54, 0.88; 1-sided p=0.0013) and hPFS (HR = 0.59, 95% CI: 0.46, 0.77; 1-sided p&lt;0.0001) were met in the EPOCH study. Median time to subsequent therapy in the TARE plus chemotherapy arm was 21.0 months, compared to 10.1 months in the chemotherapy only arm (HR = 0.49, 95% CI: 0.37, 0.67). TTDQoL before subsequent therapy was reported in 53.5% (115/215) patients in the TARE plus chemotherapy arm, compared to 43.7% of patients in the chemotherapy only arm (93/213). Median TTDQoL was 3.8 months in both the TARE plus chemotherapy arm and the chemotherapy alone arm (1-sided p=0.1513; HR = 0.86, 95% CI: 0.65, 1.14). AUC for PFS until 22.1 months was 9.4 months (95% CI: 8.4, 10.4) for the TARE plus chemotherapy arm, compared to 7.4 months (95% CI: 6.6, 8.1) for the chemotherapy only arm (1-sided p=0.0008). AUC for hPFS until 22.1 months was 10.3 months (95% CI: 9.2, 11.3) for the TARE plus chemotherapy arm, compared to 7.4 months (95% CI: 6.7, 8.2) for the chemotherapy only arm (1-sided p&lt;0.0001). AUC for TTDQoL until 18.5 months was 6.6 (95% CI: 5.6, 7.6) for the TARE plus chemotherapy arm, compared to 5.5 (95% CI: 4.4, 6.5) for the chemotherapy only arm (1-sided p=0.0663). Conclusions: These results suggest that the addition of TARE to second-line chemotherapy in patients with liver-dominant mCRC extended PFS, hPFS, and time to subsequent treatment without compromising quality of life. Clinical trial information: NCT01483027.

Is the Management of Rectal Cancer Using a Watch and Wait Approach Feasible, Safe and Effective in a Publicly Funded General Hospital?

AimsAlthough there is emerging evidence to suggest equivalent oncological outcomes using a watch and wait approach compared with primary total mesorectal excision surgery, there is a paucity of evidence about the safety and efficacy of this approach in routine clinical practice. Here we report the long-term outcomes and quality of life from patients managed with watch and wait following a clinical complete response (cCR) to neoadjuvant therapy. Materials and methodsPatients with adenocarcinoma of the rectum with cCR following neoadjuvant therapy managed using watch and wait were retrospectively identified. Demographic data, performance status, pretreatment staging information, oncological and surgical outcomes were obtained from routinely collected clinical data. Quality of life was measured by trained clinicians during telephone interviews. ResultsOver a 7-year period, 506 patients were treated for rectal cancer, 276 had neoadjuvant therapy and 72 had a cCR (26.1%). Sixty-three were managed with watch and wait. Thirteen patients had mucosal regrowth. There was no significant difference in the incidence of metastatic disease between the surgical and watch and wait cohorts (P = 0.38). The 13 patients with mucosal regrowth underwent salvage surgery. Eleven of the patients who underwent surgical resection had R0 resections. There was also a statistically and clinically significant improvement in the Functional Assessment of Cancer Therapy – Colorectal (FACT-C) trial outcome index (P = 0.022). ConclusionThis study shows that watch and wait is safe and effective outside of tertiary referral centres. It suggests that an opportunistic cCR is durable and when mucosal regrowth occurs it can be salvaged. Finally, we have shown that quality of life is probably improved if a watch and wait approach is adopted.

Associations of Household Income with Health-Related Quality of Life Following a Colorectal Cancer Diagnosis Varies With Neighborhood Socioeconomic Status.

Existing evidence indicates household income as a predictor of health-related quality of life (HRQoL) following a colorectal cancer diagnosis. This association likely varies with neighborhood socioeconomic status (nSES), but evidence is limited. We included data from 1,355 colorectal cancer survivors participating in the population-based Puget Sound Colorectal Cancer Cohort (PSCCC). Survivors reported current annual household income; we measured HRQoL via the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) tool. Using neighborhood data summarized within a 1-km radial buffer of Census block group centroids, we constructed a multidimensional nSES index measure. We employed survivors' geocoded residential addresses to append nSES score for Census block group of residence. With linear generalized estimating equations clustered on survivor location, we evaluated associations of household income with differences in FACT-C mean score, overall and stratified by nSES. We used separate models to explore relationships for wellbeing subscales. We found lower household income to be associated with clinically meaningful differences in overall FACT-C scores [<$30K: -13.6; 95% confidence interval (CI): -16.8 to -10.4] and subscale wellbeing after a recent colorectal cancer diagnosis. Relationships were slightly greater in magnitude for survivors living in lower SES neighborhoods. Our findings suggest that recently diagnosed lower income colorectal cancer survivors are likely to report lower HRQoL, and modestly more so in lower SES neighborhoods. The findings from this work will aid future investigators' ability to further consider the contexts in which the income of survivors can be leveraged as a means of improving HRQoL.

Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study.

Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).

The affect of personality traits and decision-making style on postoperative quality of life and distress in patients undergoing pelvic exenteration.

Our aim was to identify whether personality traits and decision-making styles affect quality of life (QoL) outcomes and levels of psychological distress following pelvic exenteration (PE). Patients undergoing PE between 2008 and 2015 were identified from a prospectively maintained database at a single quaternary referral centre. Patients were invited to complete two validated questionnaires, with the Big Five inventory being used to assess personality traits and the Melbourne Decision Making Questionnaire to determine decision-making style. Data on QoL outcomes and distress from the prospectively established database were utilized. QoL with respect to both physical and mental health components was measured using Short Form 36 version 2 (SF-36v2) and the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). Distress was measured using the Distress Thermometer. Postoperative pain scores were also measured using SF-36v2. Of the 93 patients eligible for participation, 42 returned the study questionnaire. On multivariate analysis, neuroticism was the most significant predictor of poorer QoL and increased levels of distress, consistent across all of the measures utilized and at the different time points used. Other personality traits showed an isolated statistically significant impact upon QoL. There were no significant findings with respect to decision-making style. Apart from neuroticism, the most significant predictor of QoL was the number of major complications for the patient. Patients demonstrating neurotic personality traits show poorer QoL outcomes and higher levels of distress following PE. Identification of these patients would allow targeted pre- and postoperative intervention to improve outcomes following PE.

Effects of dietary and physical activity interventions on generic and cancer-specific health-related quality of life, anxiety, and depression in colorectal cancer survivors: a randomized controlled trial

PurposeTo assess the effects of dietary and physical activity (PA) interventions on generic and cancer-specific quality of life (QoL), anxiety, and depression levels among adult Chinese colorectal cancer (CRC) survivors.MethodsTwo-hundred twenty-three adult CRC survivors within 1 year of completion of primary cancer treatment were randomized to receive dietary, PA or combined intervention, or usual care for a 12 monthduration, under a 2 (diet vs usual care) × 2 (PA vs usual care) factorial design. Generic and cancer-specific QoL was assessed using a Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale, respectively. Anxiety and depression was assessed using the Hospital Anxiety and Depression Scale at baseline, 6, 12, 18, and 24 months. Linear mixed models were used for examining the intervention effects.ResultsParticipants receiving dietary intervention experienced a significant improvement in the generic measure of QoL (SF-6D utility scores, mean difference 0.042, 95%CI 0.03 to 0.081) at 12 months, the cancer-specific QoL scores (mean difference 3.09, 95%CI 0.13 to 6.04), and levels of depression (P = 0.015) at both 12 and 24 months follow-up. Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.ConclusionsDietary intervention improved the generic and cancer-specific QoL and depression in CRC survivors.Trial registrationThe study was prospectively registered on 17 October 2012 at ClinicalTrials.gov (NCT01708824).Implications for Cancer SurvivorsCRC survivors can benefit from dietary interventions in alleviating depression and improving overall health-related QoL.

Effect of physical activity trackers and daily text messages on quality-of-life in colorectal survivors (Smart Pace): A pilot randomized controlled trial.

559 Background: There are over 1.3 million colorectal cancer (CRC) survivors in the United States, and many of whom suffer from lower health-related quality-of-life (HRQoL) years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. Methods: We conducted a two-arm randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at baseline and 12 weeks using the RAND Short Form Survey (SF-36) and the Functional Assessment of Cancer Therapy – Colorectal (FACT-C). Survey score changes from baseline to 12 weeks were compared between the two arms using independent t-tests, and scores at baseline and 12 weeks were compared using paired t-tests. SAS was used for analysis, and statistical significance was declared at p &lt; 0.05. Results: We observed a statistically significant increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- and post- intervention (mean ∆ 1.81 ± 2.76; p: 0.02). There was no change in functional well-being in the control arm (mean ∆ -0.35 ± 4.12; p: 0.71). The between-arm comparison of change from baseline to 12 weeks was not statistically significantly ( p: 0.08). There was a statistically significant increase in the FACT-C emotional well-being sub-scale in the control arm (mean ∆ 1.20 ± 2.48; p: 0.04) and in the SF-36 role physical sub-scale in the control arm (mean ∆ 22.5 ± 38.8; p: 0.02). No other measures of HRQoL were statistically significantly different within groups, across time points, or between groups. Conclusions: A 12-week physical activity intervention using a Fitbit Flex™ and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors, and if the improvement can be sustained over time. Clinical trial information: NCT02966054.

A systematic review examining quality of life following pelvic exenteration for locally advanced and recurrent rectal cancer.

Pelvic exenteration is a complex surgical procedure associated with considerable morbidity. Quality of life (QoL) is a crucial metric of surgical outcome. The aim of this review was to assess the QoL following pelvic exenteration for locally advanced rectal cancer (LARC) and local recurrent rectal cancer (LRRC). A comprehensive search of studies published between 2000 and 2016 that examined QoL outcome following pelvic exenteration was performed. Functional Assessment of Cancer Therapy - Colorectal (FACT-C), SF-36 version 2, European Organization for Research and Treatment of Cancer QLQ-C30, and Brief Pain Inventory assessments from these studies were reviewed. Seven studies reporting on 382 patients were included. Baseline QoL was the strongest predictor of postoperative QoL. Female gender, total pelvic exenteration with or without bone resection, and positive surgical margins were associated with a reduced QoL. In the majority of patients, QoL gradually improved between 2 and 9months post-operation. QoL is an important patient-reported outcome. This review highlights factors associated with reduced postoperative QoL that should be borne in mind when surgical resection is being considered.

Follow-up after rectal cancer: developing and testing a novel patient-led follow-up program. Study protocol

Background: The main treatment for non-metastatic rectal cancer (RC) is surgical resection. Late adverse effects that are highly prevalent and negatively impact patients’ symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. Patients and clinicians have requested a more patient-centred follow-up, balancing the focus on detection of recurrence, and physiological and psychological late adverse effects. The current follow-up program primarily focuses on detection of recurrence, with less attention on late adverse effects. As a consequence, the randomized controlled trial Follow-up after Rectal Cancer (FURCA) has been launched, testing the effect of a new patient-led, follow-up program. The aim of this paper is to describe the methodology used in the FURCA study and to report results from the development of the patient-led, follow-up program. Adult patients, treated with curative intent for primary adenocarcinoma in the rectum are included from four Danish centers.Material and methods: Patients are randomized into an intervention group, receiving standardized education and access to self-referral to an assigned project nurse, or a control group following the current follow-up program with routine medicals. The primary outcomes are symptom burden and quality of life, measured by the Functional Assessment of Cancer Therapy – Colorectal (FACT-C) questionnaire. Other outcome and demographic data are collected as patient-reported measures and register-based data.Results from developing the intervention: The education program is based on data from two focus group interviews and the feedback from experts. An algorithm is developed in order to qualify the research nurses’ responses to patients’ self-referral.Discussion and perspectives: The results of the FURCA study will strengthen the evidence base for RC follow-up, and qualify the ongoing transformation in cancer follow-up programs.